Unique UK Packaging Settlement signed between Sharpak Aylesham Restricted, Zoono, and OSY

This indication is authorised based mostly on total response price (ORR) and length of response (DOR). Continued approval for this indication could also be contingent upon verification and outline of medical profit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and the primary and solely remedy authorised for this affected person inhabitants. ADCs are designed to focus on distinctive biomarkers such because the c-Met protein and ship a potent ‘payload’ on to the biomarker-expressing cell.

Roughly 85% of lung cancers are categorized as NSCLC ^4,5 and regardless of advances in remedy, lung most cancers stays the main reason for cancer-related deaths all through the world. ¹ The c-Met protein is discovered to be overexpressed in roughly 25% of superior EGFR wild sort, non-squamous NSCLC sufferers and is related to poor prognosis. ^2,6-12 Roughly half of those sufferers have excessive c-Met overexpression, outlined as ≥ 50% of tumor cells with sturdy (3+) staining by immunohistochemistry (IHC) check. ²

“We’ve noticed a paradigm shift in oncology in latest a long time towards personalised, biomarker-driven therapeutics, permitting for higher choice and optimized remedy outcomes,” stated Jonathan Goldman , MD, professor of drugs, director of thoracic oncology medical trials, UCLA . “Folks with c-Met overexpressing NSCLC have poor prognosis and restricted remedy choices, and EMRELIS is a first-in-class ADC that may deal with a essential unmet want for this affected person inhabitants.”

“EMRELIS, AbbVie’s first internally developed stable tumor medication and our first stable tumor FDA approval in lung most cancers, is a testomony to our dedication to develop most cancers therapies that purpose to enhance the course of remedy for sufferers going through this difficult illness,” stated Roopal Thakkar, MD, govt vp, analysis and improvement, chief scientific officer, AbbVie. “Leveraging superior expertise and knowledge science, we’re rising our ADC portfolio designed to ship the precise medicines to the precise sufferers in want throughout a spread of difficult-to-treat tumors.”

“Regardless of the progress now we have seen within the remedy of lung most cancers, we’d like extra choices for folks whose therapies cease working,” stated Upal Basu Roy , PhD, MPH, govt director of analysis, LUNGevity Basis, a number one lung most cancers nonprofit group. “This approval is a welcomed focused remedy for these with excessive c-Met protein overexpressing late-stage, non-small cell lung most cancers who’ve seen very restricted remedy innovation within the final decade.”

The FDA accelerated approval is supported by knowledge from the Section 2 LUMINOSITY research ( NCT03539536 ), a research designed to characterize the efficacy and security of EMRELIS in c-Met overexpressing superior NSCLC populations. Findings from the research confirmed sufferers with excessive c-Met protein overexpression (n=84) who acquired EMRELIS demonstrated a 35% (95% CI: 24, 46) General Response Fee (ORR) and Length of Response (DOR) with a median of seven.2 months (95% CI: 4.2, 12). The commonest antagonistic reactions (≥20%) have been peripheral neuropathy, fatigue, decreased urge for food and peripheral edema. The commonest Grade 3 or 4 laboratory abnormalities (≥2%) have been decreased lymphocytes, elevated glucose, elevated alanine aminotransferase, elevated gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium. ²

In December 2021, the FDA granted EMRELIS Breakthrough Remedy Designation (BTD) based mostly on Section 2 LUMINOSITY research knowledge.

EMRELIS is being additional evaluated as a monotherapy in sufferers with beforehand handled c-Met overexpressing NSCLC within the randomized Section 3 confirmatory international research TeliMET NSCLC-01 . Enrollment within the research is underway and continues throughout international medical trial websites. Further info on medical trials for EMRELIS is obtainable at www.clinicaltrials.gov .

The FDA has additionally authorised the Roche VENTANA ^® MET (SP44) RxDx Assay, the one IHC companion diagnostic that identifies sufferers eligible for remedy with EMRELIS. To find out c-Met protein biomarker standing, sufferers could be examined on latest or archived tissue.

Concerning the LUMINOSITY Trial
The LUMINOSITY trial (NCT03539536) is an ongoing Section 2 research designed to determine the goal NSCLC populations that overexpress c-Met greatest fitted to telisotuzumab vedotin-tllv monotherapy within the second-line or third-line setting, after which to develop the teams to additional consider efficacy within the chosen populations. The endpoints embody total response price (ORR), length of response (DOR), illness management price (DCR) and progression-free survival (PFS) per impartial central overview (ICR) in addition to total survival (OS). ²

Affected person Entry and Assist
AbbVie is dedicated to serving to folks entry EMRELIS and different medicines, together with providing a affected person assist program and co-pay card that will scale back out-of-pocket prices to as little as $0 monthly for eligible, commercially insured sufferers. Monetary assist may also embody reimbursement for out-of-pocket prices associated to IV administration. For these with restricted or no medical health insurance, AbbVie presents myAbbVie Help, a affected person help program that gives EMRELIS at no cost to those that qualify. Extra info could be discovered at www.AbbVie.com/PatientAccessSupport .

About EMRELIS
EMRELIS (telisotuzumab vedotin-tllv) is a first-in-class c-Met-directed antibody-drug conjugate (ADC) comprising of a c-Met-binding antibody, cleavable linker and the monomethyl auristatin E (MMAE) payload designed to focus on c-Met expressing cells. ³ The c-Met protein is a receptor tyrosine kinase that may be overexpressed in NSCLC and is related to poor prognosis. ^{2, 6-12}

EMRELIS (telisotuzumab vedotin-tllv) U.S. Makes use of and Necessary Security   Info ³

What’s EMRELIS?
EMRELIS is a prescription medication used to deal with adults with non-squamous non-small cell lung most cancers (NSCLC):

• that has unfold to areas close to the lungs (regionally superior) or to different components of the physique (metastatic), and
• whose tumors have excessive c-Met protein overexpression, and
• who’ve acquired a previous remedy.

Your healthcare supplier will carry out a check to verify EMRELIS is best for you.

It’s not recognized if EMRELIS is protected and efficient in kids.

IMPORTANT SAFETY INFORMATION
  What’s an important info I ought to learn about EMRELIS?
  EMRELIS may cause severe uncomfortable side effects, together with:

• Nerve issues in your fingers or ft (peripheral neuropathy). Nerve issues are frequent throughout remedy with EMRELIS and can be extreme. Inform your healthcare supplier in case you develop any new or worsening indicators or signs of nerve issues, together with:

• Lung issues. EMRELIS may cause lung issues that could be extreme, life-threatening or that will result in loss of life. Inform your healthcare supplier instantly in case you develop new or worsening lung signs, together with:

• Eye issues. Your healthcare supplier might ship you to a watch care skilled to examine your eyes in case you develop eye issues. Inform your healthcare supplier instantly in case you develop any new or worsening eye issues or imaginative and prescient adjustments, together with:

• Infusion-related reactions. EMRELIS may cause infusion reactions that may be extreme or life-threatening. Inform your healthcare supplier instantly in case you develop any indicators and signs of infusion reactions, together with:

Getting medical remedy instantly might assist maintain these issues from changing into extra severe. Your healthcare supplier will examine you for these issues throughout your remedy with EMRELIS and should present remedy on your uncomfortable side effects. Your healthcare supplier might also want to vary your dose, quickly cease, or fully cease remedy with EMRELIS in case you have extreme uncomfortable side effects.

Earlier than receiving EMRELIS, inform your healthcare supplier about your whole medical situations, together with in case you:

• have a historical past of nerve issues
• have lung or respiratory issues aside from your lung most cancers
• have eye issues
• have liver issues
• are pregnant or plan to grow to be pregnant. EMRELIS can hurt your unborn child.
  • Females who’re capable of grow to be pregnant:
    • Your healthcare supplier ought to do a being pregnant check earlier than you begin remedy with EMRELIS.
    • You need to use efficient contraception (contraception) throughout remedy and for two months after your final dose of EMRELIS.
    • Inform your healthcare supplier in case you grow to be pregnant or assume that you could be be pregnant throughout remedy with EMRELIS.
  • Males with feminine companions who’re capable of grow to be pregnant:
    • You need to use an efficient contraception throughout remedy and for 4 months after taking the final dose of EMRELIS
• are breastfeeding or plan to breastfeed. It’s not recognized if EMRELIS passes into your breast milk. Don’t breastfeed throughout remedy with EMRELIS and for 1 month after the final dose.

Inform your healthcare supplier about all of the medicines you are taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. Taking sure medicines with EMRELIS might enhance your threat of uncomfortable side effects.

How will I obtain EMRELIS?

• Your healthcare supplier provides you with EMRELIS into your vein by way of an intravenous (IV) line over half-hour.
• EMRELIS is given 1 time each 2 weeks.
• Your healthcare supplier will resolve what number of infusions of EMRELIS you’ll obtain.

What are the doable uncomfortable side effects of EMRELIS?
  EMRELIS may cause severe uncomfortable side effects. See ‘What’s an important info I ought to learn about EMRELIS?”

The commonest uncomfortable side effects of EMRELIS embody:

• feeling drained
• decreased urge for food
• swelling within the ft, ankles, legs, or fingers

The commonest extreme irregular laboratory checks outcomes of EMRELIS embody:

EMRELIS might trigger fertility issues in females and males, which can have an effect on the power to have kids. Discuss to your healthcare supplier in case you have issues about fertility.

These are usually not all of the doable uncomfortable side effects of EMRELIS.

Name your physician for medical recommendation about uncomfortable side effects.

You might be inspired to report damaging uncomfortable side effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.

In case you are having problem paying on your medication, AbbVie might be able to assist. Go to AbbVie.com/PatientAccessSupport to study extra.

Please see the Full Prescribing Info and Medicine Information .

About AbbVie in Oncology
At AbbVie, we’re dedicated to reworking requirements of look after sufferers residing with difficult-to-treat cancers. We’re advancing a dynamic pipeline of investigational therapies throughout a spread of most cancers varieties in each blood cancers and stable tumors. We’re specializing in creating focused medicines that both impede the replica of most cancers cells or allow their elimination. We obtain this by way of numerous focused remedy modalities and biology interventions, together with small molecule therapeutics, antibody-drug conjugates (ADCs), Immuno-Oncology-based therapeutics, multi-specific antibody and in situ CAR-T platforms. Our devoted and skilled staff joins forces with modern companions to speed up the supply of potential breakthrough medicines.

Immediately, our expansive oncology portfolio contains authorised and investigational therapies for a variety of blood and stable tumors. We’re evaluating greater than 20 investigational medicines in a number of medical trials throughout a number of the world’s most widespread and debilitating cancers. As we work to have a outstanding impression on folks’s lives, we’re dedicated to exploring options to assist sufferers acquire entry to our most cancers medicines. For extra info, please go to http://www.abbvie.com/oncology .

About AbbVie
AbbVie’s mission is to find and ship modern medicines and options that resolve severe well being points immediately and deal with the medical challenges of tomorrow. We try to have a outstanding impression on folks’s lives throughout a number of key therapeutic areas together with immunology, oncology, neuroscience and eye care – and services and products in our Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com . Observe @abbvie on LinkedIn,   Fb , Instagram , X (previously Twitter) , and YouTube.

AbbVie Ahead-Wanting Statements  
Some statements on this information launch are, or could also be thought-about, forward-looking statements for functions of the Personal Securities Litigation Reform Act of 1995. The phrases “imagine,” “count on,” “anticipate,” “challenge” and comparable expressions and makes use of of future or conditional verbs, typically determine forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties that will trigger precise outcomes to vary materially from these expressed or implied within the forward-looking statements. Such dangers and uncertainties embody, however are usually not restricted to, challenges to mental property, competitors from different merchandise, difficulties inherent within the analysis and improvement course of, antagonistic litigation or authorities motion, adjustments to legal guidelines and rules relevant to our trade, the impression of world macroeconomic components, similar to financial downturns or uncertainty, worldwide battle, commerce disputes and tariffs, and different uncertainties and dangers related to international enterprise operations. Further details about the financial, aggressive, governmental, technological and different components that will have an effect on AbbVie’s operations is ready forth in Merchandise 1A, “Danger Components,” of AbbVie’s 2024 Annual Report on Type 10-Ok, which has been filed with the Securities and Trade Fee, as up to date by its Quarterly Experiences on Type 10-Q and in different paperwork that AbbVie subsequently information with the Securities and Trade Fee that replace, complement or supersede such info. AbbVie undertakes no obligation, and particularly declines, to launch publicly any revisions to forward-looking statements because of subsequent occasions or developments, besides as required by regulation.

Disclosure: Johnathan Goldman, MD has monetary pursuits associated to AbbVie.

References

1. American Most cancers Society. Key statistics for lung most cancers. 2025. Out there at: https://www.most cancers.org/most cancers/varieties/lung-cancer/about/key-statistics.html. Accessed Could 2, 2025 .
2. Camidge DR, et al. Telisotuzumab Vedotin monotherapy in sufferers with beforehand handled c-Met protein-overexpressing superior nonsquamous EGFR-wildtype non-small cell lung most cancers within the Section II LUMINOSITY trial. J Clin Oncol . 2024 Sep 1 ;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6 . PMID: 38843488; PMCID: PMC11361350.
3. EMRELIS [package insert]. North Chicago, IL : AbbVie Inc: 2025.
4. Nationwide Most cancers Institute. Non-small cell lung most cancers remedy – well being skilled model. https://www.most cancers.gov/varieties/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc. Accessed Could 2, 2025 .
5. American Most cancers Society. Most cancers details & figures 2025. American Most cancers Society; 2025. Out there at: https://www.most cancers.org/content material/dam/cancer-org/analysis/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf . Accessed Could 2, 2025 .
6. Bar, J. et al. 1397P Prevalence, molecular characterization, and prognosis of MET–overexpressing non-small cell lung most cancers (NSCLC) in a real-world affected person cohort. Ann Oncol , Quantity 34, S799 – S800.
7. Le X, Aggarwal C, Simmons A, et al. METPRO: Evaluating prognostic worth of c-Met protein overexpression and concurrent biomarker presence. Ann Oncol . 2024;35(S2):S829.
8. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. International most cancers statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 international locations. CA: A Most cancers Journal for Clinicians . 2024;74(3):229-63.
9. Ansell PJ, Baijal S, Liede A, et al. Prevalence and characterization of c-Met–overexpressing non-small cell lung most cancers (NSCLC) throughout medical trial samples and real-world affected person cohorts from the Metropolis of Hope Nationwide Medical Middle. Most cancers Analysis UK (CRUK) – Lung Most cancers Convention; Manchester , UK2022.
10. Liang H, Wang M. MET Oncogene in non-small cell lung most cancers: Mechanism of MET dysregulation and brokers concentrating on the HGF/c-Met Axis. Onco Targets Ther . 2020;13:2491-510.
11. Park S, Choi YL, Sung CO, et al. Excessive MET copy quantity and MET overexpression: poor consequence in non-small cell lung most cancers sufferers. Histol Histopathol . 2012;27(2):197-207.
12. Guo B, Cen H, Tan X, et al. Prognostic worth of MET gene copy quantity and protein expression in sufferers with surgically resected non-small cell lung most cancers: a meta-analysis of printed literatures. PLoS One . 2014;9(6):e99399.

View authentic content material to obtain multimedia: https://www.prnewswire.com/news-releases/us-fda-approves-emrelis-telisotuzumab-vedotin-tllv-for-adults-with-previously-treated-advanced-non-small-cell-lung-cancer-nsclc-with-high-c-met-protein-overexpression-302455629.html

SOURCE AbbVie